Data Governance Framework for Quality Control in Pharmaceutical Products

This article describes the study of data governance for quality control process in pharmaceutical industry based on data governance framework. It is necessary for the data governance framework in the pharmaceutical industry to focus on data integrity because it is regulatory compliance according to PIC/S standard. This study is action research which studies 3chemical laboratories of The Government Pharmaceutical Organization (GPO) and proposes a risk assessment procedure for assessing data in quality control process. The risk assessment procedure in data governance aims to improve data governance for data integrity compliance appropriately. The risk assessment in this study found that in the quality control process, 15 out of 63 risk items were at the high level-risk. Moreover, the results of the assessment were used to determine data controls and design a performance assessing tool to check the effectiveness of data governance for data integrity compliance in the pharmaceutical industry.